12-Step Implementation Checklist of ISO 13485 Quality Management System of Medical Devices Standard

12 Step Implementation Checklist of ISO 13485 Quality Management System of Medical Devices Standard

The chosen medical device standard in the medical sector, ISO 13485 guarantees that all medical devices adhere to consumer and regulatory requirements. ISO 13485 certification is a vital certificate that ensures the safety of professionals and patients in clinics, hospitals, and other medical environments.

ISO 13485:2016 is a management system standard established expressly for the manufacture of medical devices that are based on the ISO 9001 process model technique. Its principal goal is to assist in the harmonization of medical device regulatory regulations. The standard enables businesses to decrease safety and legal concerns while establishing more cost-effective work conditions. ISO 13485 certification, as an internationally recognized standard of quality and safety for medical device manufacture, assists organizations in being perceived as more respectable, trustworthy providers.

If the organization is considering implementing a QMS (Quality Management System) and becoming ISO 13485 certified, they may be wondering where – and how – to begin. To get started, here are the 12 actions you must take to ensure you don’t miss anything as you move through your implementation and prepare for certification.

  • Get management support. Without management support, your ISO 13485 implementation project is destined to fail. This is why it’s step one. You must create a thoughtful presentation describing the advantages ISO 13485 implementation will bring to your business and win the support of the management team from the outset.
  • Identify requirements. Making sure you identify each requirement that the QMS must meet is the next crucial stage towards a successful implementation. Depending on the needs and culture of your firm, these criteria may also include customer requirements, legal and regulatory requirements, and others.
  • Define the scope. While you don’t want to apply the QMS to parts of your business that don’t deal with quality, you also don’t want to make the scope so small that the firm doesn’t notice any advantages. You will have a clearer understanding of what has to be done and the parameters of your implementation once you have defined the QMS’s scope. The quality manual and quality policy are your finest resources for aiding in scope definition; as such, they should be the initial ISO 13485 documents you create for your QMS.
  • Define processes and procedures. You will need to decide which processes and procedures inside your organization must be established to assure acceptable and consistent quality. The ISO 13485 standard specifies a number of necessary procedures that must be included in your QMS. The first step is to characterize every process used by your business, after which you may examine how those processes relate to one another. These conversations are frequently where issues surface.
  • Implement processes and procedures. For the majority of businesses, ensuring consistent quality that complies with regulations only requires the documenting of current processes and procedures. To ensure consistency in the quality of your products and services, you don’t have to record every process; instead, you must choose which procedures require a written method.
  • Deploy training and awareness programs. The effectiveness of your quality management system depends on every employee in your company being aware of how it functions and how they fit within it. All staff members must receive basic ISO 13485 auditor training to understand the purpose behind adoption as well as any upcoming modifications to the processes they are a part of.
  • Choose a certification body. The correct certification body can make all the difference because it is this organization that will audit your Quality Management System after deployment to see if it complies with ISO 13485 requirements. They will also determine whether your QMS is efficient and exhibits continuous development.
  • Operate the QMS / Measure the system. During this time, you will gather the documentation needed to support your processes’ adherence to established standards, their effectiveness, and the ongoing improvement of your QMS. To ensure that the system is developed enough to demonstrate compliance, certification bodies require that this occurs over a specific period, which they will specify.
  • Conduct internal audits. You must carry out an internal audit of each process after using the QMS for the required amount of time but before the certifying authority does its audit. This will let you know whether or not the procedures are working as intended, and if not, you’ll have the chance to fix any problems you notice.
  • Conduct a management review. Management must actively participate in the continuing upkeep of the Quality Management System in addition to supporting the company’s implementation of ISO 13485. Data from the QMS activities will be analyzed during the management review to ensure that all processes have the resources they require to remain efficient and advance over time.
  • Take corrective action. When issues are found by internal audits, measures, and management reviews, this is where you look for the underlying causes and take the required steps to address them. This is an essential stage in the Quality Management System’s ongoing improvement, which is one of ISO 13485’s main objectives.
  • Perform the certification audit. The time has come for the auditors from your preferred certification body to check the documents and confirm that your QMS complies with all ISO 13485 requirements.
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